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目的 采用多中心、单盲随机分组和安慰剂对照方法 ,观察增生平对食管癌高发区食管上皮增生患者的治疗作用。方法 选择食管癌高发地区河北磁县现场 40～ 6 5岁居民 ,先进行食管细胞学检查 ,对筛选出的食管上皮增生患者 ,再进行食管镜活检病理确诊。根据患者性别、年龄及食管病变的级别 (轻、中、重度 )进行分层随机分组。 44 9例食管上皮增生的患者随机分为两组 :治疗组 30 0例 ,口服增生平每次 8片 ,每天 2次 ,共服 6个月 ;对照组 149例 ,口服安慰剂每次 8片 ,每天 2次 ,共服6个月。为确保试验的准确性 ,两组药品中均加入适量核黄素作为指示剂 ,并定期测定患者的尿样本。结果 99%的患者均定期服药 ,在治疗组可评价疗效的 30 0例患者中 ,好转者 193例 (6 4 3 % ) ;而对照组 149例中 ,好转者仅为 34例 (2 2 .8% ) ,两组差异有极显著性 (χ2 =6 8.6 7,P <0 .0 0 1)。治疗组中病变加重者 10例 (3 .3% ) ,对照组 37例 (2 4.8% ) ,差异有极显著性 (χ2 =49.0 9,P <0 .0 0 1)。结论 增生平是治疗食管上皮增生的有效药物
Objective To investigate the therapeutic effects of proliferating cell in patients with esophageal epithelial hyperplasia in high-risk areas of esophageal cancer using multi-center, single-blind randomization and placebo-controlled methods. Methods Elective esophageal cytology was performed on 40-65-year-old residents in Ci County, Hebei Province, a high-incidence area of esophageal cancer. Esophageal biopsy was performed on the selected patients with esophageal hyperplasia. Stratified randomization was based on the gender, age, and grade of esophageal lesions (light, moderate, and severe). Fourty-nine patients with esophageal epithelial hyperplasia were randomly divided into two groups: 300 in the treatment group, 8 tablets for oral hyperplasia, 2 times per day for 6 months; 149 patients in the control group and 8 tablets for each placebo , 2 times a day for a total of 6 months. In order to ensure the accuracy of the test, appropriate amount of riboflavin was added as an indicator in both groups of drugs, and the patient’s urine samples were measured periodically. Results 99% of patients received regular medications. Of the 300 patients who could evaluate the efficacy in the treatment group, 193 (64.4%) were found to be improved. In the 149 patients of the control group, only 34 (116) were improved. 8%), the difference between the two groups was extremely significant (χ2 = 6 8.6 7, P <0. 0 0 1). In the treatment group, 10 cases (3.3%) were aggravated, and 37 cases (2 4.8%) were in the control group. The difference was extremely significant (χ2 = 49.0 9, P < 0.01). Conclusion Hyperplasia is an effective drug for the treatment of esophageal epithelial hyperplasia